Spain, through the European Union route · European Medicines Agency · New drugs
Review target
210 days
regulation
Legal time limit
-
Not published
Steps
8
13 requirements
Application fee
€865,200
From 2025-01-01
One application to the European Medicines Agency leads to one marketing authorisation valid in every EU country. The agency's committee for human medicines gives an opinion within 210 active days. The European Commission then takes the binding decision. Required for biotechnology medicines, advanced therapies, designated orphan medicines and new active substances for listed diseases such as cancer, diabetes and viral diseases. Optional for other new active substances.
The official review target is 210 days (regulation). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The centralised marketing authorisation application, new active substance claimed (all strengths, forms and presentations) is €865,200 for From 2025-01-01.
1. Pre-submission and eligibility; 2. Initial assessment and list of questions (120 days); 3. First clock stop: applicant answers; 4. Further assessment and list of outstanding issues (60 days); 5. Second clock stop (if needed); 6. Committee opinion (30 days); 7. Re-examination (optional); 8. Commission decision (67 days).
Outcome: A Commission decision grants one marketing authorisation for the whole EU. It is valid for five years and can then be renewed. New medicines get eight years of data protection and ten years of market protection, with one extra year possible for a significant new indication. Valid for 5 years.
Legal basis: Regulation (EC) No 726/2004; Directive 2001/83/EC, Article 8(3)
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
About 458 days end to end with the official step targets, of which up to 121 days are clock stops (time the applicant uses to answer). Targets, not actual times.
From the official approvals data of this market, all products of this pathway type and segment
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Decisionofficial guidance. Time for the Commission decision after the agency recommendation, as stated by the agency. | 67 days |
| Review targetregulation. Maximum active days for the committee opinion. Official target days, not actual review times. Days the applicant spends answering questions do not count. | 210 days |
| Typical total timeofficial guidance. The agency says the assessment of a new medicine usually lasts around a year, including clock stops. This is a general statement, not a target. | 365 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Centralised marketing authorisation application, new active substance claimed (all strengths, forms and presentations)Application · From 2025-01-01 · SMEs: payment deferred until the decision. Designated orphan medicines: 10% reduction, or 100% for SMEs. Paediatric use applications: 50% reduction. | €865,200 |
| Annual fee per centrally authorised product (full applications and other products not covered by the generic or biosimilar annual fees)Yearly · From 2025-01-01 · SMEs: 40% reduction; micro enterprises: 100% reduction. | €232,400 |
Other routes in Spain: Centralised authorisation of advanced therapy medicinal products, Centralised marketing authorisation, known active substance or new fixed combination, Centralised hybrid application, Centralised biosimilar application, Centralised well-established use application, Device with an ancillary medicinal substance: medicines authority consultation, Accelerated assessment, Conditional marketing authorisation, Authorisation under exceptional circumstances, PRIME (priority medicines), Orphan designation, Paediatric investigation plan, Integral drug-device combination authorised as a medicine, Decentralised procedure, Mutual recognition procedure. See all routes on the Spain page or explore them in the Regulatory section.
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (34 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.